FDA 510(k)

WOLF 靈栓切除系統，6F

K 號：K210530 · 2021-08-27

決定日期2021-08-27

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

WOLF Thrombectomy System, 6F is the device name listed in this FDA 510(k) record. The listed applicant is Devoro Medical, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210530. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WOLF Thrombectomy System, 6F?

WOLF Thrombectomy System, 6F is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Devoro Medical, Inc.. The 510(k) number is K210530.

When did WOLF Thrombectomy System, 6F receive FDA 510(k) clearance?

WOLF Thrombectomy System, 6F received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210530.

Who is the listed applicant for WOLF Thrombectomy System, 6F?

The FDA 510(k) record lists Devoro Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOLF Thrombectomy System, 6F?

The FDA product code for WOLF Thrombectomy System, 6F is QEW.

其他以 Devoro Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：QEW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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